Comparative Study of Efficacy of 10 mg Dequalinium Chloride (Fluomizin) in the Local Treatment of Bacterial Vaginosis
NCT ID: NCT01125410
Last Updated: 2010-05-18
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
PHASE3
321 participants
INTERVENTIONAL
2007-01-31
2009-02-28
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Study Evaluating the Efficacy and Safety of Miconazole Nitrate + Domiphen Bromide Vaginal Cream in the Treatment of Subjects With Acute Vulvovaginal Candidiasis
NCT04813822
Tolerability and Pharmacokinetic Study of Econazole Nitrate and Benzydamine HCl Intravaginal Cream
NCT02713893
A Study to Compare Efficacy and Safety of an Ovule Containing Terconazole, Clindamycin and Fluocinolone Versus an Ovule Containing Metronidazole, Nystatin and Fluocinolone in the Treatment of Secondary Vulvar/ or Vaginal Symptoms of Infectious Vaginitis/ and Infectious Vaginosis
NCT01867164
Evaluate Efficacy, Tolerability & Safety of Combination of Clindamycin and Ketoconazole for the Treatment of Mixed-Type Vaginosis, Bacterial Vaginosis and Candidiasis
NCT00889356
Tolerability and Pharmacokinetic Study of Econazole Nitrate Plus Benzydamine HCl Vaginal Pessary
NCT02720783
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Dequalinium chloride 10mg
Dequalinium chloride
Vaginal tablet, 10mg, 1 tablet daily for 6 days
clindamycin vaginal cream 2%
Clindamycin
vaginal cream, 2%, once daily for 7 days
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Dequalinium chloride
Vaginal tablet, 10mg, 1 tablet daily for 6 days
Clindamycin
vaginal cream, 2%, once daily for 7 days
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* Women aged 18-55 years
Exclusion Criteria
* Uterine bleeding (including menstruation but not including cervical contact bleeding on sampling) or vaginal bleeding of unknown origin
* Acute infections of the upper genital tract
* Clinical Symptoms of a vulvovaginal Candidiasis
* Use of anti-infectives (local or systemic) in the previous 14 days and/or during the study
18 Years
55 Years
FEMALE
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Medinova AG
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Medinova AG
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Ernst Rainer Weissenbacher, MD
Role: PRINCIPAL_INVESTIGATOR
Klinik und Poliklinik für Frauenheilkunde und Geburtshilfe, LMU Munich
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
AZ Imelda Ziekenhuis
Bonheiden, , Belgium
AZ St. Dimpna
Geel, , Belgium
AZ Ziekenhuis Oost-Limburg
Genk, , Belgium
AZ Heilig Hart
Tienen, , Belgium
Centrum Ambulantni gynekologie a prodnictvi
Brno, , Czechia
Faculty Hospital Brno
Brno, , Czechia
University Hospital Hradec Kralove
Hradec Králové, , Czechia
Charles University
Prague, , Czechia
Fakultni nemocnice Na Bulovce
Prague, , Czechia
Ambulance pro gynekologie a prodnictvi
Telč, , Czechia
LMU Munich
Munich, , Germany
JLF UK a MFN
Martin, , Slovakia
University Hospital of Geneva and Faculty of Medicine
Geneva, , Switzerland
CHUV
Lausanne, , Switzerland
Countries
Review the countries where the study has at least one active or historical site.
References
Explore related publications, articles, or registry entries linked to this study.
Weissenbacher ER, Donders G, Unzeitig V, Martinez de Tejada B, Gerber S, Halaska M, Spacek J; Fluomizin Study Group. A comparison of dequalinium chloride vaginal tablets (Fluomizin(R)) and clindamycin vaginal cream in the treatment of bacterial vaginosis: a single-blind, randomized clinical trial of efficacy and safety. Gynecol Obstet Invest. 2012;73(1):8-15. doi: 10.1159/000332398. Epub 2011 Dec 24.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
Med380104
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.